Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma

A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: OT-730 ophthalmic solution; Drug: timolol maleate ophthalmic solution; Drug: OT-730 placebo

Detailed Description

Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.

The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States
  • Georgia
    • Roswell, Georgia, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • High Point, North Carolina, United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy subjects, 18 to 80 years of age, any gender
• diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension

Exclusion Criteria:

• have VA worse than 20/200,
• cataract that compromises visualization of fundus,
• history of lack of response to ocular beta blocker therapy,
• uncontrolled intraocular pressure,
• angle closure glaucoma or occludable angles,
• retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study,
• a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc),
• chronic use of steroids,
• any disease that, in the opinion of the investigator, may put the patient at significant risk,
• taking systemic beta blockers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; OT-730 ophthalmic solution	Drug: OT-730 ophthalmic solution; one eye drop twice daily
Active Comparator: 2; timolol maleate ophthalmic solution	Drug: timolol maleate ophthalmic solution; one eye drop twice daily
Placebo Comparator: 3; placebo eye drops	Drug: OT-730 placebo; one eye drop twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the safety profile of OT-730	8 days
Change from baseline in intraocular pressure	Day 6

Collaborators and Investigators

• Sponsor: Othera Pharmaceuticals

Publications and helpful links

Helpful Links

• Othera Pharmaceuticals, Inc. website

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 15, 2008
• First Posted (Estimate): September 16, 2008

Study Record Updates

• Last Update Posted (Estimate): January 7, 2009
• Last Update Submitted That Met QC Criteria: January 6, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: OT-730-C01